Antibiotic Razgrad AD sell "Fungocap"
Basic Information
369
19
6
3.7(19)
Category
Subcategory & Sub-subcategory
Trade Type
Sell
Product Name
Fungocap
Details
Manufacturer(s)
Specifications
- Capsule Fill Weight: Controlled to ±5% of target fill weight per capsule, verified by in-process weight checks
- Content Uniformity: Meets USP <905>/Ph.Eur. 2.9.6 content uniformity acceptance value (AV ≤ 15) across the batch
- Container Closure Integrity: Validated per USP <1207> to ensure the container-closure system prevents microbial ingress and maintains product sterility/stability through shelf life
Other Information
Additional Description:
Fungocap (INN: fluconazole) is supplied as capsules at 150 mg or 200 mg strength, in packs of 1 (single blister), 7 (strip of 7), 10, 20, or 30 capsules (strips of 10). Shelf life 3 years; batch sizes of 50,000, 150,000, or 200,000 capsules; marketing authorization in place; dossier in eCTD format.
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